WO2017071335A1 - Vis creuse poreuse en métal de tantale - Google Patents

Vis creuse poreuse en métal de tantale Download PDF

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Publication number
WO2017071335A1
WO2017071335A1 PCT/CN2016/091730 CN2016091730W WO2017071335A1 WO 2017071335 A1 WO2017071335 A1 WO 2017071335A1 CN 2016091730 W CN2016091730 W CN 2016091730W WO 2017071335 A1 WO2017071335 A1 WO 2017071335A1
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WO
WIPO (PCT)
Prior art keywords
screw
base metal
thread
nut
metal hollow
Prior art date
Application number
PCT/CN2016/091730
Other languages
English (en)
Chinese (zh)
Inventor
赵德伟
王本杰
谢辉
黄诗博
尉晓蔚
王威
Original Assignee
赵德伟
王本杰
谢辉
黄诗博
尉晓蔚
王威
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN201510712216.5A external-priority patent/CN105147383B/zh
Priority claimed from CN201520845079.8U external-priority patent/CN205083596U/zh
Application filed by 赵德伟, 王本杰, 谢辉, 黄诗博, 尉晓蔚, 王威 filed Critical 赵德伟
Priority to EP16858774.9A priority Critical patent/EP3222234B1/fr
Publication of WO2017071335A1 publication Critical patent/WO2017071335A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • A61B17/8605Heads, i.e. proximal ends projecting from bone
    • A61B17/861Heads, i.e. proximal ends projecting from bone specially shaped for gripping driver
    • A61B17/862Heads, i.e. proximal ends projecting from bone specially shaped for gripping driver at the periphery of the screw head
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/74Devices for the head or neck or trochanter of the femur
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • A61B17/866Material or manufacture
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/08Materials for coatings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • A61B17/8625Shanks, i.e. parts contacting bone tissue
    • A61B17/863Shanks, i.e. parts contacting bone tissue with thread interrupted or changing its form along shank, other than constant taper
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • A61B17/864Pins or screws or threaded wires; nuts therefor hollow, e.g. with socket or cannulated

Definitions

  • the present invention relates to a medical permanent implant, and more particularly to a porous base metal cannulated screw for a medical implant for the treatment of a femoral neck fracture.
  • Femoral neck fractures are common clinical diseases. There is also some controversy about its treatment. Most researchers believe that the treatment principle of fresh femoral neck fracture should be early, anatomical reduction and firm fixation; however, the internal fixation method is basically fixed with hollow compression screws. At present, hollow screws made of titanium metal are often used in clinical practice. Although some clinical effects have been achieved, they have no clinical disadvantages such as induced bone formation and secondary extraction.
  • Porous medical metal implant materials have important and special applications for treating bone tissue wounds and inducing bone tissue regeneration. Common materials such as porous stainless steel and porous titanium are common materials.
  • the porous implant material used for the treatment of wound and defect of bone tissue should have a porosity of 30-85%, and the pores are preferably all connected and evenly distributed, or the pores are connected and evenly distributed according to the need, so that the human body is The growth of the bone tissue is consistent, and the weight of the material itself is reduced to be suitable for human implantation.
  • Metal ruthenium has no side effects on human body, and has good biocompatibility and mechanical properties. Its porous material is expected to replace the traditional medical metal biomaterials and become the main biological material in the treatment of femoral neck fracture. With the rapid development of medicine at home and abroad, and the further recognition of sputum as a human implant material, the demand for porous metal ruthenium materials for human body implantation has become more and more urgent, and the requirements for it have become higher and higher. Among them, as a porous medical implant metal crucible, if it has a high uniform distribution of connected pores and physical and mechanical properties compatible with the human body, it is an important connecting member constituting material for ensuring the normal growth of new bone tissue.
  • U.S. Patent 5,282,861 discloses an open-cell material for use in cancellous bone implants, cells and tissue susceptors and preparation thereof.
  • the porous crucible is made of pure commercial crucible, and the carbon skeleton obtained by thermal degradation of the polyurethane precursor is a scaffold.
  • the carbon skeleton has multiple dodecahedrons, and the inside is a grid-like structure, and the whole is distributed throughout the micro-frame.
  • the pores have a porosity of up to 98%, and the commercial pure ruthenium is bonded to the carbon skeleton by chemical vapor deposition and permeation to form a porous metal microstructure, which is referred to as a chemical deposition method.
  • the porous tantalum material obtained by this method has a tantalum layer thickness of 40-60 ⁇ m on the surface; In the material, the specific gravity of the crucible is about 99%, and the weight of the carbon skeleton is about 1%.
  • the literature further describes that the porous material has a compressive strength of 50-70 MPa, an elastic modulus of 2.5-3.5 GPa, a tensile strength of 63 MPa, and a plastic deformation amount of 15%.
  • porous perforated metal hollow screws made of medical implants for the treatment of femoral neck fractures using existing porous tantalum materials have disadvantages such as poor biomechanical and biocompatibility, and how to improve their mechanical strength and biology. Compatibility is an important issue.
  • the hollow compression screw used for clinical fixation of femoral neck fracture has various structures, such as hollow screws made of metal titanium, with a short triangular thread structure, hollow screws made of other materials, and the tail.
  • the nail caps are mostly circular structures.
  • problems such as complicated structure, weak biomechanical efficiency, insufficient mechanical strength, and need for secondary removal.
  • problems such as internal fixation screw fracture and fracture displacement are often encountered.
  • porous beryllium metal hollow screw for use in a femoral neck fracture in view of the problems associated with the prior art hollow compression screws.
  • the porous base metal hollow screw has simple structure, good mechanical strength, good biological performance, firm internal fixation performance, high tissue compatibility and biomechanical properties, can induce bone tissue formation, and is convenient for bone tissue length.
  • a porous base metal hollow screw comprising a screw and a nut, the screw and the nut are integrally formed, and the outer surface of the front section of the screw has a thread, wherein the length of the thread and the screw length ratio are 1 : 0.7-2.3, preferably 1:2;
  • the nut is a conical nut having a cylindrical nail head, the angle of the tapered surface of the conical nut and the center line of the screw is 44-46 °,
  • the outer surfaces of the two sides of the cylindrical nail head are symmetrically opened with a groove center line, the two inclined surfaces of the groove are at an angle of 60°, and the central axis of the screw is provided with a through hole, the thread and the screw There is a smooth slider between the caps.
  • the pitch of the thread is 3.7-4.3 mm, preferably 4 mm
  • the width of the thread is 1.7-2.3 mm, preferably 2 mm
  • the difference between the outer diameter and the inner diameter of the thread is 7-13 of the screw diameter.
  • the angle of the thread is 90 ⁇ 2 °; the thread design is advantageous for the screw to reduce the resistance during the screwing process and to reduce the need for the conventional screw to self-tapping with other instruments before screwing in.
  • the deepening of the thread is conducive to the firm fixation of the fracture site.
  • the depth of the groove is 7-13%, preferably 10%, of the diameter of the screw.
  • the thickness of the nut is 7-13%, preferably 10%, of the length of the screw.
  • the design enhances the gripping force of the hollow screw tail and is firmly fixed to the cortical part to prevent the screw from reversing and the fracture displacement.
  • the thread is triangular. This design reduces the self-attack process before the screw enters, reduces further bone loss, and strengthens the internal fixation strength of the fracture.
  • flank angle of the thread is 30°-50°. This design facilitates the fixing of the screw.
  • the diameter of the through hole is 77-83%, preferably 80%, of the diameter of the screw.
  • a section of the screw away from the nut is a screw front end, and the front end of the screw has a conical shape with an apex angle of 30 to 120°.
  • the above-mentioned hollow screw adopts a material obtained by reducing a base metal compound into a base metal powder by a chemical vapor deposition method, and uniformly depositing a surface of the graphite carbon skeleton to form a tantalum coating, wherein the base metal compound is prepared.
  • the material for preparing the porous base metal hollow screw has a porosity of 85%, a pore diameter of 200-600 ⁇ m, and a network structure in which at least 80% of the polyhedrons are interwoven, and a dodecahedral network structure having a three-dimensional communication of pores It is conducive to the growth of bone cells and tissues.
  • the invention also provides a preparation method of the above porous tantalum metal hollow screw, the preparation method comprising the following steps:
  • the processing gas comprises a base metal compound and a carrier gas
  • the base metal compound is placed in a source tank, heated to 120-250 ° C, and an inert gas of 300 ° C is used as a carrier gas to the reaction chamber;
  • the inert gas is a mixture of one or both of argon gas and helium gas;
  • the flow rate of the processing gas is 80-100 ml/min
  • the flow rate of the hydrogen gas is 100-150 ml/min.
  • porous base metal cannulated screw of the present invention can be applied to a medical implant for treatment of nonunion, bone defect, and prosthetic reconstruction after tumor resection.
  • the screw at the front end of the present invention is longer than a conventional hollow screw, and a nut having a cylindrical nail head is used, and a rectangular groove having a specific angle (60°) is provided on the cylindrical nail head. Conducive to the screwing in and the secure fixing of the hollow screw, preventing the occurrence of displacement of the fracture, and well overcoming the square or round nut in the prior art and the design of the countersunk hole directly arranged on the nut. Disadvantages of the cortical bone and the unreliable fixation during use;
  • the screw of the invention can avoid the disadvantage of deformation of the tail when the screw is screwed, so that the force reaches the front end uniformly, and the possibility of deformation and breakage of the screw is reduced; the nut has a pressing effect and has a better holding and fixing function; The deformation and fracture of the thread when implanting hard bone such as cortical bone; no need for secondary surgery to remove the pain.
  • the porous base metal hollow screw of the invention is beneficial to the formation of new bone and the replacement of bone, especially in the treatment of femoral neck fracture, and overcomes the effect of the existing titanium alloy "cannulated screw" in clinical treatment. insufficient.
  • the material of the porous base metal hollow screw of the present invention has a dodecahedral three-dimensional network structure, and the structure is similar to that of the cancellous bone trabecular bone, and has high tissue compatibility, can induce bone tissue formation, and is convenient for bone.
  • the porous base metal hollow screw of the invention has simple preparation method and low cost, is favorable for implementation and clinical application, and is suitable for the needs of a large number of patients.
  • Figure 1 is a schematic view showing the structure of a cannulated screw of the present invention.
  • a porous base metal hollow screw includes a screw 1 and a nut 2, and the screw 1 and the nut 2 are integrally formed, and the outer surface of the front portion of the screw 1 has a thread 11 and the thread
  • the ratio of the length of the 11 to the length of the screw 1 is 1:2
  • the nut 2 is a tapered nut having a cylindrical nail head, and the angle of the tapered surface of the tapered nut is 45° with the center line of the screw.
  • the outer surfaces of the two sides of the cylindrical nail head are screwed
  • the center line is symmetrically opened with a groove 21, and the angle between the two inclined faces of the groove 21 is 60°.
  • the center axis of the screw 1 is provided with a through hole, and the thread 11 and the nut 2 are smooth and slippery. Rod.
  • the thread 11 has a pitch of 4 mm, the thread 11 has a width of 2 mm, the difference between the outer diameter and the inner diameter of the thread 11 is 10% of the diameter of the screw 1, and the angle of the thread 11 is 91°; 11 Design favorable screw screwing reduces the self-tapping process and the deepening of the thread 11, which is conducive to the strong fixation of the fracture site.
  • the depth of the groove 21 is 10% of the diameter of the screw 1.
  • the thickness of the nut 2 is 10% of the length of the screw 1; the design strengthens the holding force of the tail of the hollow screw, and is firmly fixed to the cortical part to prevent the screw from falling backward and the fracture to be displaced.
  • the thread 11 is triangular, and the design reduces the self-tapping process before the screw enters, reduces the further loss of bone, and strengthens the internal fixation strength at the fracture.
  • the flank angle of the thread 11 is 35°, which is advantageous for the fixing of the screw.
  • the diameter of the through hole is 80% of the diameter of the screw 1.
  • a section of the screw 1 remote from the nut 2 is a screw front end 12 having a conical shape with an apex angle of 120° and a screw front end having a length of 3.3% of the screw length.
  • the specific size of the screw can be appropriately adjusted to achieve the best therapeutic effect.
  • the porous base metal hollow screw described in Example 1 was prepared as follows:
  • the porous beryllium metal hollow screw body material has a porosity of 85%, an elastic modulus of 10 GPa, and a maximum compressive strength of 35 MPa.
  • the porosity is according to the national standard GB/T 21650.1-2008, and the elastic modulus is It is tested according to the method described in the national standard GB/T 22315-2008.
  • the porous base metal hollow screw body material has a dodecahedral network structure with three-dimensional connected pores, and the structure is similar to the cancellous bone trabeculae, has high tissue compatibility, can induce bone tissue formation, and is convenient for bone Long-term tissue; and has strong biomechanical properties, can provide a certain degree of mechanical support, to promote fracture healing and repair, filling bone defects.
  • the graphite carbon skeleton is first processed into the shape described in Fig. 1, and then the porous tantalum metal hollow screw of the invention is prepared through the steps (1) to (2).

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Abstract

Cette vis creuse poreuse en métal de tantale comprend une tige filetée (1) et une tête de vis (2), la tige filetée (1) et la tête de vis formant un tout solidaire. La face externe de l'extrémité avant de la tige filetée (1) comporte un filetage (11) dont le rapport de longueur avec la tige filetée est de 1 : 1,7-2,3. La tête de vis (2) est une tête de vis de forme annulaire dont le bout adopte une configuration cylindrique, la surface conique de la tête de vis (2) de forme conique formant avec la ligne centrale de la tige filetée (1) un angle incliné compris entre 44 et 46 °, et la surface externe des deux côtés de la tête de vis de forme cylindrique présentant de manière symétrique une rainure (21) avec la ligne centrale de la tige filetée (1). L'angle incliné des deux plans obliques de la rainure (21) est de 60°, l'axe central de la tige filetée (1) étant perforé d'un trou passant. Entre le filet (11) et la tête de vis (2) vient la tige filetée (1) de manière régulière. La structure de la vis creuse présente l'avantage de s'enrouler et de s'ancrer fermement de manière à éviter que l'emplacement d'une fracture d'os ne se déplace et à empêcher que, lors du vissage de la vis, la partie de queue ne se déforme, ce qui a pour effet d'assurer que la force atteigne l'extrémité avant de manière uniforme et de réduire, par conséquent, le risque de déformation et de rupture de la vis.
PCT/CN2016/091730 2015-10-28 2016-07-26 Vis creuse poreuse en métal de tantale WO2017071335A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP16858774.9A EP3222234B1 (fr) 2015-10-28 2016-07-26 Vis creuse poreuse en métal de tantale

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN201510712216.5A CN105147383B (zh) 2015-10-28 2015-10-28 一种多孔钽金属空心螺钉及其应用
CN201510712216.5 2015-10-28
CN201520845079.8U CN205083596U (zh) 2015-10-28 2015-10-28 一种多孔钽金属空心螺钉
CN201520845079.8 2015-10-28

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WO2017071335A1 true WO2017071335A1 (fr) 2017-05-04

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EP (1) EP3222234B1 (fr)
WO (1) WO2017071335A1 (fr)

Citations (11)

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JPH08238265A (ja) * 1994-12-01 1996-09-17 Johnson & Johnson Professional Inc モジユラー膝プロテーゼ
CN1269198A (zh) * 1999-04-01 2000-10-11 陈永铵 一种具有交锁固定结构的股骨颈及头固定螺钉
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CN202069679U (zh) * 2011-05-24 2011-12-14 山东省文登整骨医院 骨螺钉
CN103083074A (zh) * 2011-11-04 2013-05-08 无锡世一电力机械设备有限公司 一种股骨颈骨折的内固定装置
CN203328868U (zh) * 2013-06-24 2013-12-11 重庆润泽医药有限公司 一种植入性股骨头
CN103462730A (zh) * 2013-09-26 2013-12-25 赵德伟 一种多孔钽棒及其应用
CN203988332U (zh) * 2014-08-21 2014-12-10 赵德伟 一种前置螺纹可降解纯镁螺钉
CN204428147U (zh) * 2014-12-27 2015-07-01 王建平 一种股骨颈固定机构及其股骨颈骨折固定结构
CN105147383A (zh) * 2015-10-28 2015-12-16 赵德伟 一种多孔钽金属空心螺钉及其应用
CN205083596U (zh) * 2015-10-28 2016-03-16 赵德伟 一种多孔钽金属空心螺钉

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US6592578B2 (en) * 2000-02-24 2003-07-15 Howmedica Leibinger, Inc. Device for locally heating a bioabsorbable plate
US8579947B2 (en) * 2009-09-14 2013-11-12 Yangguan Wu Polyporous hollow bone screw

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08238265A (ja) * 1994-12-01 1996-09-17 Johnson & Johnson Professional Inc モジユラー膝プロテーゼ
CN1269198A (zh) * 1999-04-01 2000-10-11 陈永铵 一种具有交锁固定结构的股骨颈及头固定螺钉
US20080262556A1 (en) * 2007-02-27 2008-10-23 Jacofsky Marc C Modular polyaxial pedicle screw system
CN202069679U (zh) * 2011-05-24 2011-12-14 山东省文登整骨医院 骨螺钉
CN103083074A (zh) * 2011-11-04 2013-05-08 无锡世一电力机械设备有限公司 一种股骨颈骨折的内固定装置
CN203328868U (zh) * 2013-06-24 2013-12-11 重庆润泽医药有限公司 一种植入性股骨头
CN103462730A (zh) * 2013-09-26 2013-12-25 赵德伟 一种多孔钽棒及其应用
CN203988332U (zh) * 2014-08-21 2014-12-10 赵德伟 一种前置螺纹可降解纯镁螺钉
CN204428147U (zh) * 2014-12-27 2015-07-01 王建平 一种股骨颈固定机构及其股骨颈骨折固定结构
CN105147383A (zh) * 2015-10-28 2015-12-16 赵德伟 一种多孔钽金属空心螺钉及其应用
CN205083596U (zh) * 2015-10-28 2016-03-16 赵德伟 一种多孔钽金属空心螺钉

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EP3222234A1 (fr) 2017-09-27
EP3222234B1 (fr) 2020-10-21
EP3222234A4 (fr) 2018-02-21

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